Healthcare

The global healthcare scenario is rapidly transforming. Customers in the medical devices industries face a multitude of challenges, including:

Time to market

Increasing Product Development costs

Adapting products for specific geographies

Managing product costs for emerging markets

Managing costs for product lifecycle management and sustenance

Modernizing legacy equipment

Tech Mahindra’s Medical Devices engineering practice is a partner of choice for global industry majors. We develop next generation products and technologies through strong domain capabilities in end to end medical product development solutions and sustenance Engineering Support. As a part of our future ready solutions, we offer a range of connected engineering solutions for the healthcare industry across real time remote patient monitoring systems, emergency response systems, etc.

Our solutions help transform healthcare delivery and drive down the insurance and medical costs. Our vision is to improve the safety and optimize the cost of healthcare. Apart from our strict adherence to all industry standards and regulations, we help our customers to:

Meet product cost targets and optimize development costs by working with you from product design and development to product verification and validation

Tech Mahindra has specialized skills in offering innovative technology solutions to the medical equipment industry. We adopt stringent process controls and conform to standards and regulatory practices to ensure quicker time to market and enable compliance.

Tech Mahindra is one of the leading engineering technology solution providers with the expertise to cater to a wide spectrum of customers in the Medical Devices industry. We have been providing engineering services and solutions to leading medical equipment and medical device manufacturers globally for several years. We offer solutions across:

Application Development

Tech Mahindra designs and delivers best in class applications to suit your business requirements. In addition to application development, our dedicated teams work constantly to explore and develop new ways to reuse and optimize existing assets, extending their life and functionality.

Medical device application development on Linux, Windows, Android and iOS

Expertise in healthcare mobility devices in home care and critical environment

In house UX designers with hands on experience in medical product user interface design

Matured software development life cycle process complying to IEC 62304

Firmware Development

Tech Mahindra has vast experience in BSP customization, porting various embedded operating systems to target boards and device driver development that will help you accelerate development and reducing development time and effort while providing error free solutions. Our engineers have experience in performance optimization for various platforms and operating systems and choose the best development platform for specific architectures. Our well-proven porting methodology will substantially reduce the porting time and development cost for accelerated time-to-market.

Tech Mahindra has flexibility in developing stand-alone solutions for customers or working as part of larger system development based on customer needs. Our embedded team has extensive experience in real-time system development and device driver development for peripherals including UART, Ethernet, PCI, USB and custom FPGAs.

Conducting engineering analysis of the design and iterate on the high-level design till functional requirements are met

We also provide a range of engineering analysis services:

Finite Element Analysis

Stress analysis

Structural analysis

Computational Fluid Dynamics Analysis

Thermal analysis

Tolerance Stack up analysis

Design for manufacturability

Design for serviceability

Our engineers are well versed in Value Engineering. We provide a range of Value Engineering services that will significantly reduce your product development and material costs:

Technical data collection

Commercial data collection

Product tear down and value analysis

Product Should Costing

Functional analysis

Idea generation

Idea evaluation

Function cost worth analysis

Reverse engineering

Re engineering

Quality Assurance and Regulatory Affairs

The demand for medical devices from global markets is a challenge for manufacturers. Ensuring safety and regulatory compliance are the biggest challenges for medical device manufacturers in delivering products efficiently. Products must meet global standard requirements as well.

Regulatory Affairs

We have a team of regulatory compliance experts with expertise in global regulatory requirements, including ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, and FDA 21 CFR Part 11 etc. We have developed a structured Global Compliance Framework that helps our customer meet regulatory compliance requirements.

Regulatory compliance for medical devices with a well-structured methodology

Implementation of privacy and security requirements

Pre-market submissions assistance – FDA510(K), PMA, MDD and SFDA

Pre-compliance testing and Gap analysis for IEC60601-1 3rd Ed for new and legacy models and certification through ecosystem partners like TUV, Intertek, UL etc.

Complete ownership in testing of new or re-engineered devices for regulatory compliance

HIPAA compliance services

Risk Management (ISO 14971:2007) consulting

Detail study and implementation of Risk Management

Regular updates on regulatory requirements

Quality Consulting

Medical device manufacturers who want to distribute their products in multiple geographies are subjected to a variety of Quality System regulations with their own unique set of requirements. We help you comply with FDA Quality System Regulation (FDA QSR) and ISO 13485:2003. In addition, we provide training, assistance in implementation and a final audit in preparation for all inspections.

Manufacturing Process Validation

Process validation is an essential part of Medical Devices engineering. There are multiple regulations like FDA QSR 820.75 and ISO 13485 7.5.2 that all manufacturing facilities must comply with. Non-compliance with these requirements may lead to FDA 483 or non-conformities. We can help you validate the medical device manufacturing process meeting 21CFR 820 /ISO 13485 requirements.

Tech Mahindra is a leader in developing next generation solutions for the global Medical Devices and Healthcare industry. While the global healthcare system is under a lot of stress from an increasing number of chronic conditions and a lack of specialist care, we are leveraging future ready technology to innovate and create transformative healthcare solutions. Our innovative, connected healthcare solutions are designed to improve healthcare delivery and take care outside the hospital walls.

Remote Patient Monitoring Solution: Successfully developed a wearable multi parameter monitoring solution that provides the flexibility of monitoring on the move. Solution consisted of remote viewers for viewing patient vitals and posture information using Android, Windows, iOS devices from any remote location through a cloud based solution. Wearable monitor had flexible connectivity options (WiFi/BLE/3G) and developed in 3 variants considering the requirements of remote home care as well as critical care needs. Features a hot Key for SOS and Event Marking.

Quality Management System Remediation: A US based device manufacturer had received multiple 483s from FDA for one of their imaging products after inspection. The Tech Mahindra QARA team worked with the customer for fixing gaps related to the Quality Management System and the entire FDA certified product DHF files. Activities involved were gap analysis of QMS, ownership of design control/CAPA processes, remediation for 5 DHFs and complaint investigations.

Ambulance Concept to Implementation: Successfully conceptualized and developed a next generation ambulance with the latest technology and improved vehicle engineering to enable ‘Reach and Care’ operations of the Emergency Management and Research Institute. The team worked on freezing product technical specifications comprising performance, safety and regulatory requirements, ambulance interior design, designing and integrating advanced vehicle tracking and management solutions and vehicle selection. Launched over 700 ambulances within six months.

Transform your business by improving patient care management, lowering product design investments and achieving faster time to market with world class Medical Device Engineering Solutions & Services uniquely tailored to suit your business needs. For more information, email us or contact us here.